Pelvic Pain Clinical Trial
Official title:
The Effect in Term of Ovarian Reserve Modification of Adding Prophylactic Bilateral Salpingectomy (PBS) to TLH for Preventing Ovarian Cancer
The aim of this RCT of study is to compare the standard TLH with adnexal preservation with TLH plus prophylactic bilateral salpingectomy (PBS) in terms of ovarian reserve and surgical outcomes
Status | Recruiting |
Enrollment | 167 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 35 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Indication to laparoscopic hysterectomy - Accomplished reproductive desire Exclusion Criteria: - Patients with a family history of ovarian cancer and with a known mutation of the BRCA1/2 genes - Patients with a current or a past history of cancer - Patients who don't consent to the prophylactic salpingectomy - Previous adnexal surgery - PCOS - Estrogen-progestin therapy in the 2 months prior to the enrollment - Acute or chronic pelvic inflammatory disorders - Malignant gynecological neoplasms - Prior chemotherapy or radiotherapy - Autoimmune diseases, chronic, metabolic, endocrine and systemic disorders, including hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease - Hypogonadotropic hypogonadism - Taking medications that can cause menstrual irregularities - Other clinical conditions |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | Chair of Obstetrics and Gynecology - University division - UMG | Catanzaro | CZ |
Lead Sponsor | Collaborator |
---|---|
University Magna Graecia |
Italy,
Morelli M, Venturella R, Mocciaro R, Di Cello A, Rania E, Lico D, D'Alessandro P, Zullo F. Prophylactic salpingectomy in premenopausal low-risk women for ovarian cancer: primum non nocere. Gynecol Oncol. 2013 Jun;129(3):448-51. doi: 10.1016/j.ygyno.2013.03.023. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ovarian reserve modification | Ovarian reserve modification will be defined as the difference (expressed as ?) between post-operative and pre-operative values of AMH, FSH, AFC, OV, VI, FI and VFI | Three months after laparoscopy | Yes |
Secondary | Operative time | Time from skin incision to skin closure | The same day of surgery | Yes |
Secondary | variation of hemoglobin level | two hours after the end of surgery | Yes | |
Secondary | postoperative hospital stay | The day of patient discharge | Yes | |
Secondary | postoperative return to normal activity | two months after surgery | No | |
Secondary | complication rate | The day of patient discharge | Yes |
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